Regenerative treatment for traumatic brain injury examined in clinical study
Phase II study will evaluate stem cell treatment for patients with chronic motor deficits 12–36 months post injury
In the United States alone, approximately 1.5 million people suffer a traumatic brain injury (TBI) annually. Many such injuries result in life-long disabilities, requiring long-term rehabilitation and care to address severe neurological deficits, including cognitive and motor function impairment.
In work that aims to address this public health issue, SanBio Inc. has begun recruiting patients for a Phase II clinical trial to study the efficacy and safety of its proprietary cell therapy for TBI. The stem cell therapy for TBI trial (STEMTRA) will investigate the effects of SanBio’s regenerative therapy, which uses SB623 cells, in patients diagnosed with chronic motor deficits resulting from focal traumatic brain injury.
Explaining the background behind the trials, SanBio’s Chief Medical Offier and Head of Research Damien Bates stated: “Focal traumatic brain injuries occur in association with the more typical diffuse injuries seen in TBI patients, and can be caused by a wide range of events such as car accidents, falls, firearm mishaps and battlefield injuries. These events often result in permanent damage, leaving a patient with significant motor deficits. Our hope is that SB623 will prove to be a safe and effective treatment option for these patients.”
Commencement of this Phase II clinical trial follows a Phase I/II trial in patients with chronic motor deficit secondary to ischemic stroke, which demonstrated statistically significant improvements in motor function following implantation with SB623 cells. The new Phase II study will further evaluate the treatment’s safety and efficacy, in addition to examining the safety and tolerability of the administration process.
The study will be conducted across approximately 25 clinical trial sites throughout the USA and is expected to recruit 52 patients.